A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT03798366
• Date of registration: 03/01/2019
• Prospective Registration: Yes
• Primary sponsor: Galapagos NV
• Public title: A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic Sclerosis NOVESA
• Scientific title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic Sclerosis
• Date of first enrolment: January 14, 2019
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03798366
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Germany, Italy, Spain, United Kingdom, United States

Contacts

• Name: Dick de Vries, MD
• Affiliation: Galapagos NV

Key inclusion & exclusion criteria

Inclusion Criteria:

- Able and willing to comply with the protocol requirements and to sign the informed
consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional
Review Board (IRB), prior to any screening evaluations.

- Male and female subjects =18 years at the time of consent who meet the American
College of Rheumatology (ACR)/EULAR 2013 diagnostic criteria for systemic sclerosis
with diffuse cutaneous involvement (according to LeRoy's criteria) and =5 years since
the onset of the first systemic sclerosis manifestation other than Raynaud's
phenomenon.

- mRSS >10 at screening.

- Active disease at screening, as defined by: Worsening of skin thickening (=2 mRSS
points) as assessed by mRSS measured at screening versus a previous mRSS assessment
made within 6 months prior to screening, or new areas of skin involvement within 6
months prior to screening as documented by physician note, or new-onset systemic
sclerosis with symptoms or signs other than Raynaud's phenomenon within 2 years prior
to screening, or =1 tendon friction rub (palpated in the finger flexors or extensors,
wrist flexors or extensors, olecranon bursa, shoulders, knees, anterior or posterior
ankles with active motion).

- Subject must be able and willing to comply with restrictions on prior and concomitant
medication as described in the protocol

- Female subjects of childbearing potential must have a negative serum pregnancy test at
screening and a negative urine pregnancy test at the baseline visit.

- Female subjects of childbearing potential or male subjects with female partners of
childbearing potential must be willing to comply with the contraceptive methods
described in the protocol prior to the first dose of the investigational medicinal
product (IMP), during the clinical study, and for at least 90 days after the last dose
of the IMP for male subjects and 30 days after the last dose of the IMP for female
subjects.

- A body mass index (BMI) between 18-35 kg/m2, inclusive, at screening.

- Judged to be in good health by the investigator based upon the results of a medical
history, physical examination, vital signs, 12-lead ECG, and fasting clinical
laboratory safety tests. Clinical laboratory safety test results must be within the
reference ranges or test results that are outside the reference ranges need to be
considered non-clinically significant in the opinion of the investigator.

Exclusion Criteria:

- Known hypersensitivity to IMP ingredients or history of a significant allergic
reaction to any drug as determined by the investigator, such as anaphylaxis requiring
hospitalization.

- Breastfeeding female or subject intending to become pregnant or breastfeed.

- History of or a current immunosuppressive condition (e.g. human immunodeficiency virus
[HIV] infection, congenital, acquired).

- Positive blood testing for hepatitis B surface antigen or hepatitis C virus (antibody,
confirmed by hepatitis C virus RNA positivity). Note: Subjects with a resolved
hepatitis A at least 3 months prior to screening can be screened.

- History of malignancy within the past 5 years (except for carcinoma in situ of the
uterine cervix, basal cell carcinoma of the skin that has been treated with no
evidence of recurrence, prostate cancer medically managed through active surveillance
or watchful waiting, and squamous cell carcinoma of the skin if fully resected and
ductal carcinoma in situ).

- Clinically significant abnormalities, in the opinion of the investigator, detected on
ECG at screening of either rhythm or conduction, QT interval corrected for heart rate
using Fridericia's formula (QTcF) >450 ms, or a known long QT syndrome.

- Unstable cardiovascular, pulmonary, or other disease (other than systemic
sclerosis-related), in the opinion of the investigator, within 6 months prior to the
baseline visit (e.g. coronary heart disease, heart failure, stroke).

- Severe pulmonary disease with forced vital capacity (FVC) =45% of predicted within 6
months prior to the baseline visit.

- Chronic or ongoing active infectious disease, including tuberculosis (requiring
hospitalization or systemic treatment within 4 weeks prior to the baseline visit).

- Abnormal liver function test (LFT) at screening, defined as aspartate aminotransferase
(AST), and/or alanine aminotransferase (ALT), and/or bilirubin, and/or alkaline
phosphatase >2x upper limit of normal (ULN). Retesting is allowed once.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Intervention(s)

Drug: GLPG1690

Drug: Placebo

Primary Outcome(s)

Change from baseline in modified Rodnan skin score (mRSS) over 24 weeks [Time Frame: At screening and Week 24]

Secondary Outcome(s)

Number of participants with adverse events (AEs) over 24 weeks as assessed by CTCAE version 5.0. [Time Frame: From screening until Week 24]

Secondary ID(s)

2018-001817-33

GLPG1690-CL-204

Source(s) of Monetary Support

Please refer to primary and secondary sponsors